Reporting on Chemical Safety and REACH Compliance with IUCLID
The International Uniform Chemical Information Database (IUCLID) has recently updated its information requirements for registering chemicals in accordance with the REACH Regulation to ensure they comply with the regulation. As a result of the streamlined formats and absoluteness check rules included in REACH, companies can easily report their compliance with REACH requirements. This helps to reduce the cost of registration for companies, as well as the time and effort required to submit the information. Additionally, IUCLID helps ensure that the data submitted is of high quality and accuracy. There has been an update to the REACH information conditions (Additions VI to XI), which has further enhanced the safety and efficiency of chemical substances within the European Union by clarifying the information conditions. These additions also provide detailed information on the requirements for registration, evaluation, and authorization of chemicals. Furthermore, the update aims to improve the transparency of the process and ensure the safety of both people and the environment. IUCLID’s update includes the following features: Revised REACH Annexes: There has been a revision to the data formats and the rules for absoluteness checks to reflect the amended information conditions within REACH. With this release, the updated completeness checks for REACH enrolments will be applied from 1 June 2023 onwards. This change will ensure that REACH enrolments are processed more quickly and accurately. Companies must be aware of these changes and adjust their procedures accordingly. Failure to do so could result in delays or rejections of their REACH enrolments. Expanded format support: With this release of IUCLID, its format is interpreted to accommodate the Drinking Water Directive requirements. Using this format, chemical substances present in drinking water can be better evaluated. IUCLID will review and finalize the format of the document in the upcoming release of IUCLID. OECD harmonized templates (OHTs): Updates and advancements to OECD (Organisation for Economic Co-operation and Development) harmonized templates The latest release incorporates updates and advancements to the OECD (Organisation for Economic Co-operation and Development) harmonized templates. For chemical testing reports to be more accurate and standardized, these templates now consider the latest revisions to the OECD test guidelines. BPR Summary of product characteristics (SPC): In the updated version of IUCLID, a streamlined format is included for the Biocidal Products Regulation (BPR), facilitating a seamless transition from the SPC Editor to IUCLID in a smooth and efficient manner. We expect that this transition will be completed by the end of this year, resulting in a streamlined biocidal product approval process. ECHA has updated its REACH and CLP manuals to reflect these changes to help companies adapt to these changes. An updated version of the Chemical Safety Assessment and Reporting Tool (Chesar), compatible with this IUCLID release, will likely be available soon. The new Chesar version will allow companies to assess the risks of using certain substances and ensure they are compliant with the latest legislation. It will also provide detailed information about chemical properties in the EU market. This will help companies ensure their products are safe for consumers. With its team of dedicated compliance engineers, ComplianceXL assists organizations with REACH compliance documentation. Our compliance engineers stay on top of the latest changes in compliance regulations across different industries to enhance the compliance status of our clients. ComplianceXL ensures compliance with REACH obligations and avoids penalties or disruptions to organizations’ operations with its expertise and in-depth knowledge. FAQs 1.What is IUCLID? In the European Union, IUCLID supports the implementation of various chemical regulations, such as the REACH regulation. A central database for chemical data submission and exchange. Chemical substance information can be accessed and evaluated by regulatory authorities and industry stakeholders. 2.What is IUCLID’s role in supporting REACH compliance? The IUCLID provides a standardized format for companies to submit their chemical data and registrations for REACH compliance. Regulatory authorities use it for risk assessment and decision-making processes after companies collect and submit comprehensive datasets on chemical properties, uses, and hazards. It facilitates effective communication between different stakeholders by collecting information in a consistent and harmonized way.
ECHA adds two new substances to the REACH SVHC list.
The European Chemicals Agency (ECHA) has updated the Candidate List of substances of very high concern, which now includes 235 hazardous chemicals. The new chemicals have been added to the REACH SVHC Candidate List to ensure a high level of protection for the environment and the health of humans when it comes to hazardous chemicals, as part of an effort to ensure a high level of protection. It should be noted that one of the chemicals added is toxic for reproduction, whereas the other has persistent and bio accumulative properties. These chemicals are used in various products such as inks, toners, plastic production, and manufacturing processes. Organizations are responsible for managing the risks associated with these chemicals and providing information to customers and consumers about their safe use. Below are the chemicals that are added to the REACH SVHC list. S.No Substance name EC number CAS number Reason for inclusion Examples of use 1 Diphenyl (2,4,6-trimethyl benzoyl) phosphine oxide 278-355-8 75980-60-8 Toxic for reproduction (Article 57c) Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modeling clay. 2 Bis(4-chlorophenyl) sulphone 201-247-9 80-07-9 vPvB (Article 57e) Manufacture of chemicals, plastic products, and rubber products. The addition of these hazardous chemicals to the Candidate List raises concerns about their potential negative impacts on human health and the environment. Lack of awareness about the presence and risks of these chemicals can lead to unsafe handling and use, posing risks to individuals and the ecosystem. Companies must fulfill their legal obligations under REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulations when their substances are included in the Candidate List. Suppliers of articles containing Candidate List substances must provide information to customers and consumers to ensure safe usage. In addition to providing a safety data sheet, suppliers of these articles above a concentration of 0.1 % (weight by weight) must inform their customers and consumers of how to safely use them. Importers, producers, and suppliers of substances on the Candidate List have specific notification and reporting requirements to ECHA to track the presence and concentration of these chemicals. If an article contains a substance on the Candidate List, importers and manufacturers must notify ECHA within six months. Notification and reporting requirements facilitate better monitoring and management of these chemicals, minimizing their negative impact on human health and the environment. ECHA’s addition of two hazardous chemicals to the Candidate List highlights the ongoing effort to identify and regulate substances that can harm people and the environment. Stricter regulations and increased transparency regarding the presence of these chemicals in products contribute to safer handling and usage. ComplianceXL helps organizations with REACH regulatory compliance services in assisting them to collect REACH information for their products. As part of our compliance data management strategy, we also assist our customers in maintaining their supplier certificates and declarations on a regular basis so that they remain up to date. Also, we will provide Maintenance services to our customers to maintain and validate the regulatory documents to make sure accurate those are up-to-date and accurate. FAQ: Q1. What is the Candidate List? A. The Candidate List is a compilation of substances of very high concern identified by the European Chemicals Agency due to their potentially harmful effects on human health or the environment. Q2. What are the benefits of the Candidate List? A. The Candidate List raises awareness about hazardous chemicals, enabling better risk management, safer product usage, and informed consumer choices. It also promotes monitoring and control of these substances, reducing their negative impact.
ECHA (European Chemicals Agency) adds 8 more substances for REACH Authorisation – 11th Recommendation kicks in.
To ensure proper control of risks for human health and the environment ECHA recommends that the European Commission adds eight substances to the REACH Authorisation List including Lead. Use of Lead in batteries, ammunition, cables, vehicles, machinery, electronics, radiation shielding, sanitary, construction, art and musical instruments comes under the scope of authorisation. As a reprotoxic substance, volume range set for lead in the scope of authorisation is >1000. The other seven recommended substances include: Ethylenediamine (CAS# 107-15-3) 2-(4-tertbutylbenzyl) propionaldehyde and its individual stereoisomers Glutaral (CAS# 111-30-8) 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (CAS# 71868-10-5) 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone (CAS# 119313-12-1) Diisohexyl phthalate (CAS# 71850-09-4) and Orthoboric acid of sodium salt group. Ethylenediamine and Glutaral cause respiratory ailments. Rest of recommended substances such as 2-(4-tertbutylbenzyl) propionaldehyde and its individual stereoisomers, 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one, 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone, Diisohexyl phthalate, Orthoboric acid, sodium salt are identified as toxic to reproduction. Most of these substances are part of other directives too. 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one and Diisohexyl phthalates are also part of the medical device directive, CMD (Conflict Minerals Declaration), CAD, ELV, WFD Directive. Glutaral is listed in cosmetic directive of EU (European Union) union. Once substances are added to the authorization list, companies will need to apply for authorisation for their specific uses. Also, companies should look for viable alternatives. The Candidate List of substances of very high concern has been prioritized by ECHA as the highest priority substances, following the 2014 agreement. Lead was included in the draft recommendation published on 2 February 2022, which generated a great deal of feedback during the consultation process. As a result, ECHA’s Member State Committee discussed the timing, the relationship with other ongoing or planned regulatory activities, and the expected workload for industry and authorities. To ensure worker and environmental protection, ECHA recommends the European Commission add eight substances to the REACH Authorization List, including lead. Adding substances to the list will require companies to apply for authorization to continue using them. With our clients, we make sure they are always compliant with global regulations and are always operating responsibly and sustainably. With our comprehensive solutions, organizations can assess their current compliance status and stay up to date on ECHA requirements. Additionally, we provide reporting services to ensure that all necessary documentation is completed accurately and on time. For information on the 11th recommendation of REACH Authorization, contact one of our compliance experts today.
REACH and RoHS: New Implications for Electronics Manufacturers
The Oeko-Institut (Institute for Applied Ecology) has issued an amended version for the report of RoHS Pack 22. Please visit Rohs News for more details. According to a recent press announcement made by EC, the next stage of REACH: “The European Commission has launched a public consultation on the revision of the REACH. The revision will aim to align EU chemical rules with the Commission’s ambitions for safe and sustainable chemicals, high levels of protection for health and the environment and preservation of the internal market. The planned REACH revision is one of the actions announced in the Chemicals Strategy for Sustainability.” Visit European Commission’s website to read more: REACH Regulation
K-REACH considers adding 10 new Candidates to the substance list
The Ministry of Environment designated chemical substances with risk concern as substances subject to authorization. It introduced the system for designation and management of substances subject to authorization in 2015. Any person who wants to manufacture, import or use the relevant substances should get authorization from the Minister of Environment. Korea. Candidate substance list and the risk assessment results According to the Article 19 and 25 of K-REACH (Act on Registration and Evaluation, Etc. of Chemical Substances), the Minister of Environment shall designate substances subject to intensive Priority control substances and other chemicals with risk concern as substances subject to authorization and make announcement, and the person who wants to manufacture, import, and use a substance subject to authorization shall prepare, submit materials regarding its use, risk and alternative analysis, and get authorization. For the pilot project, below ten chemical substances are selected as candidate substances. These chemicals fall under the category of CMR(Carcinogenicity, Mutagenicity, Reproductive toxicity), PBT(Persistent·Bioaccumulative·Toxic) or endocrine disruptors. Substance name CAS No. Status of designation of Priority Control substances Assigned number Hazard Benzo[def]chrysene (Benzo[a]pyrene) 50-32-8 1-2 CMR, PBT Benz[a]anthracene 56-55-3 2-7 CMR, PBT Formamide 75-12-7 1-16 CMR p-(1,1-dimethylpropyl)phenol 80-46-6 1-28 Endocrine disorders Tris(2-chloroethyl) phosphate 115-96-8 1-67 CMR Sodium peroxoborate 7632-04-4 1-125 CMR Perboric acid, sodium salt 11138-47-9 1-161 CMR Sodium Tetraborate, Pentahydrate 12179-04-3 1-164 CMR 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) 15571-58-1 1-175 CMR Trixylyl phosphate 25155-23-1 1-181 CMR 50-32-8 , Benzo[a]pyrene, is used in paints or coatings as corrosion protection coats. 56-55-3, Benz[a]anthracene is used in synthesis of anti-tumor agents. 75-12-7, Formamide is used as an intermediate in agrochemical, pharmaceutical and paper finishing industries. 80-46-6, p-(1,1-dimethylpropyl)phenol is used to control microbial pests on hard surfaces or laundry, used in washing machines to clean fabrics, Septic system treatment products. 115-96-8 , Tris(2-chloroethyl) phosphate is used as a flame retardant in plastics, especially inflexible foams used in automobiles and furniture and in rigid foams used for building insulation. 7632-04-4, Sodium peroxoborate serves as a stable source of active oxygen in many detergents, laundry detergents, cleaning products, and laundry. 11138-47-9, Perboric acid, sodium salt used in bleach-containing cleaning products, in particular in laundry detergents and machine. 12179-04-3, Sodium Tetraborate, Pentahydrate is used in the manufacture of enamels and glazes, fiberglass insulation. 15571-58-1 ,2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) is mainly used in the production of plastic products. 25155-23-1 Trixylyl phosphate is generally used as a flame retardant in hydraulic fluids and as a plasticizer. The Minister of Environment of Korea reviewed summaries of risk supporting the selection of these candidate substances based on each substance’s hazard, the volume of domestic distribution, and existing risk assessment performed in Korea and abroad. At ComplianceXL, we provide compliance consultancy services across various compliance regulations, and also assist organizations with compliance documentation enabled by our supplier engagement team. If you have any questions or need any help, please contact one of our compliance specialists today.
Turkey REACH and its Implications
Turkey REACH law is like EU REACH and requires the companies to pre-register (by 31 Dec 2020) and register (31 Dec 2023) substances (on their own, in mixtures or in articles) manufactured in Turkey or imported into Turkey with volumes equal to or above 1 ton per year. This is called as KKDIK. KKDIK stands for Turkish for Registration, Evaluation, Authorization and Restriction of Chemicals. Only one representative (OR) can be appointed by companies to submit KKDIK registration and CLP notification on their behalf. There are no separate deadlines set depending on the classification of the substance or the annual tonnage band, for pre-registration and registration. Submissions for Pre-MBDF will be accepted after 31 Dec 2020 All registrations must be completed between 31 Dec 2020 – 31 Dec 2023 After 31st Dec 2023,substances that are equal to or above one ton per annum, cannot be place or manufactured in Turkish market, If they are not registered as per KKDIK provisions. KKDIK came into force on 23rd Dec 2017 and replace below 3 regulations in Turkey. The Inventory and Control of Chemical Regulation (KEK) – Effective from 23, Jun 2017 Regulation on Restrictions for the Manufacture, Marketing and Use of certain Dangerous Substances and preparation – Effective from 23 December, 2017. Regulation on Safety Data Sheets for Hazardous Substances and Mixtures (GBF)- Effective from 31 December, 2023. Below are the main obligations that is under KKIDK: Notification on MBDF- Deadline is 31 Dec 2020 Registration – Deadline is 31 Dec 2023 Authorization – Date/substance in Annex XIV determined by the MoEU (Turkish Ministry of Environment and Urbanization) Restriction – Dates Annex XVII (Article 66 of KKDIK regulation) Below substances and Mixtures are not covered by KKDIK: Radioactive substances Goods in free-zone for re-export Non-isolated intermediates Transport of dangerous substances and mixtures by various modes Substances manufactured or imported for defense purpose Medicinal products Cosmetic products Veterinary products Food and feeds Medical devices Active substances and co-formulants that are only manufactured or imported for using in plant protection products need to be registered under Turkey REACH. Active substances approved for biocidal products also need to be registered. GHS safety data sheet and labelling are still needed for the plant protection products and biocidal products, that are exempt from KKDIK. Candidate list for Turkey REACH is same as that of EU candidate list. The main key difference between EU REACH and Turkey REACH is that, KKDIK, requires only trained and qualified experts sign off and registrations and notifications. There are no other major differences between EU REACH and Turkey REACH.
ECHA publishes SCIP data
ECHA has released the first public database of SCIP, which contains the results of testing on substances of very high concern. The SCIP database is a comprehensive and systematic compilation of chemical information on substances including potential adverse effects. This SCIP database allows consumers to be informed about their products and facilitates recycling and reusing of them. The EU’s new SCIP database available to the public will help in the development and use of safer chemicals, and in identifying alternatives to hazardous substances for which there is no appropriate alternative. There are around 6000 companies that have successfully comply with notifying SVHCs (Substance of high concern) in SCIP. There are more than four million article notifications in the database. It includes details on when restrictions were imposed, how they can be used safely if they are not banned, their potential risks and examples of where they have been subject to restrictions elsewhere in the world. This will help authorities in member states identify potentially harmful substances more quickly when new ones are brought onto their markets. Based on the information available; below are the common product categories that are notified. Furniture Vehicle and parts of vehicle Measuring instruments Electronic equipment Machinery and its parts Rubber products/article Below are the most common substances that are notified by the companies: Dechlorane Plus, found in paints and Glue Lead Monoxide, found in Vehicle parts, lamps Lead, found in batteries and Ball bearings Lead titanium trioxide found in electronic items Silicid acid or lead salt found in Vehicle coatings and leaded crystalware The data can be searched by Product category, chemical name, type of category, brand or article name. This data will help the consumers in buying products of their choice by understanding any hazardous substance in the product. Waste operators utilize the data to enhance the reuse of products.
All you need to know about PFCAs restricted by EU under Annex 17
PFCAs (perfluorocarboxylic acids), a subset of PFAs (per- and polyfluoroalkyl substances) has been restricted by European commission – under Annex XVII of REACH Regulation. This new regulation replaces the entry 68 of Annex 17 to REACH on PFOA. PFOA related substances are now regulated under POPs regulation (EU) 2019/1021. It restricts the PFCAs and their salts, containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs). The below substances are excluded from the definition: CnF2n+1-C (= O) OX’ where n> 13 and X’=any group, including salts CnF2n+1-X, where X = F, Cl, or Br where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof. Companies cannot manufacture, use or place the PFCAs and their salts on the market from 25th Feb 2023. These are toxic and very persistent and very bioaccumulative (vPvB). C9-C14 PFCAs act as a substitute for PFOA. This is also added under Candidate List as substances of very high concern (SVHCs) under REACH. It can be used as a constituent in other substances, mixtures or articles, if the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances. The regulation is applicable from 4th July 2023 to: Textiles for oil – and water repellency for protection of workers from dangerous liquids. The manufacturer of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF), used in the production of: Industrial sealants capable of preventing volatile organic compound leakage. Equipment for industrial waste heat exchange. Membranes used in corrosion resistant gas filters, water filters and medical devices. The regulation is applicable from 4th July 2025 for: Photographic coatings applied to films. Implantable and invasive medical devices. Fire-fighting foam for liquid fuel vapor suppression and liquid fuel fire for Class B fires. photolithography or etch processes used in the manufacture of semiconductors. Different transition periods are granted to certain industry and professional. Articles placed before 25th of Feb 2023 on EU market are exempted. Talk to one of our REACH Regulation Specialists today!
Did you know? ECHA has identified 300 chemicals as candidates for regulatory action
On 21 April 2021, ECHA published its third report on Integrated Regulatory Strategy. It provides latest information on Agency’s work regarding the identification and management of chemicals that are hazardous. It aims at accelerating data generation, identifying of groups of substances of concern, and regulatory action. Last year, ECHA addressed the chemical with similar structure in groups instead of each chemical individually. This increased the total number of chemicals assessed in 2020 to 1900.As per the report, RMOA (Regulatory management option analysis) it was concluded that 290 substances were identified for further regulatory risk management. These chemicals require more data to be submitted and hazard confirmation before taking any regulatory action. These substances include potential CMRs, few potential EDs, PBTs and respiratory sensitizers. The conclusion will be shared and publicly available on ECHA’s website by end of 2021. Under EU legislation, harmonized classification is a prerequisite for risk management actions. Over 100 chemicals identified would warrant harmonized classification, but still not picked up by the authorities. Lack of harmonized classification can cause a delay in risk management action by the authorities, The progress is made in clarifying the need for regulatory action of substances registered above 1 ton. ECHA recommend that, while the agency continue to work on optimizing group approach for substances: Member states, without delay should initiate regulatory risk management for the substances that require further action. Member states should collaborate with each other to maximize their outcome of work. Industries should make use of the developed programs to help them to review and update the REACH Dossiers. Updates must be done proactively, even before authorities take regulatory actions. ECHA aims to provide clarification by 2027 for which registered substances are a high priority for regulatory risk management or data generation, and which are currently a low priority for further regulatory action. Talk to one of our global compliance specialist today!
Did you know ECHA added 2 new substances to SVHC?
European Union (EU) added 2 additional substances to its REACH SVHC list as on 19th January 2021 and the total number of SVHCs is now 211 substances. This addition is continuation to the publication consultation conducted between September 2020 and October 2020.REACH, REACH SVHC, REACH 211, REACH Update, ECHA REACH, EU REACH Update, NEW REACH SVHC Here are the 2 Substances added to existing list of REACH SVHC. 1. Bis(2-(2-methoxyethoxy)ethyl)ether CAS number – 143-24-8 Reason – Toxic for reproduction The release of this substance to the environment is from the products such as inks and toners, feminine hygiene products, nappies, books, magazines, machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners, welding & soldering products, plant protection products and extraction agents. 2. Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety This group of substance has 3 group members. dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. Stannane, dioctyl-, bis(coco acyloxy) derivs. CAS No.: 91648-39-4 These are known to be used across a wide variety of product categories, including as stabilizers and catalysts in the production of materials such as plastics and rubber. Dioctyltin dilaurate CAS No.: 3648-18-8 This is a substance found in adhesives, sealants, coating products, paper chemicals & dyes, polymers, textile treatment products & dyes, washing & cleaning products, fillers, putties, plasters, modelling clay, pH regulators & water treatment products and leather treatment products. Reason – Toxic for reproduction The REACH Regulation puts forth obligations to organizations when these substances are included in their parts or products. As per the regulation, any product containing SVHC substances above a concentration of 0.1 % weight by weight, the organization has to provide sufficient usage information for safety, within six months of including the substance into REACH SVHC. Talk to our REACH Compliance Specialist today!